Last month marked the first time ever that the U.S. Food and Drug Administration (FDA) requested a drug company pull a painkiller of the market due to high potential for abuse. Endo International PLC announced Thursday it would abide by that request and stop selling Opana ER.
Opana ER’s removal from the market is the final chapter in a series of moves against the drug.
In a March hearing, FDA advisers voted 18 to 8 against keeping Opana ER on the market. The agency reviewed the hearing and requested Endo stop marketing the drug in June.
While the drugmaker contended that the extended-release opioid is safe and effective when used as intended, the FDA has concluded that the drug is too risky to remain on the market, citing a shift from people crushing and snorting the pill to get high to injecting it instead.
In fact, Opana ER was blamed for a 2015 outbreak of HIV and hepatitis C in southern Indiana linked to the sharing of needles.
This outbreak happened after a 2012 formulation change which was meant to make the drug harder to abuse. Endo wished to market the new formulation as abuse deterrent; however, the FDA denied Endo’s marketing request.